User talk:Thecharisp: Difference between revisions

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The Arbitration Committee has authorised discretionary sanctions to be used for pages regarding pseudoscience and fringe science, a topic which you have edited. The Committee's decision is here.

Discretionary sanctions is a system of conduct regulation designed to minimize disruption to controversial topics. This means uninvolved administrators can impose sanctions for edits relating to the topic that do not adhere to the purpose of Wikipedia, our standards of behavior, or relevant policies. Administrators may impose sanctions such as editing restrictions, bans, or blocks. This message is to notify you sanctions are authorised for the topic you are editing. Before continuing to edit this topic, please familiarise yourself with the discretionary sanctions system. Don't hesitate to contact me or another editor if you have any questions.

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The PAP-IMI comes under this heading. Your only actions on Wikipedia have been to promote it, you may not do that. Guy (Help!) 23:04, 15 April 2014 (UTC)[reply]

PAP-IMI is a medical device! Whoever created the article categorized it as pseudoscience on purpose in order to make it look bad! What is stated in the current "article" is partially untrue anymore and only one side of the story, or at least a very specific event and no mention of several others. Thus making it look very bad, while there are several positive facts to share as well! I am undoing your removal. I thought that wikipedia is objective... Thank you. Thecharisp 00:10, April 16, 2014‎ (UTC)

That's not our judgement, it is the judgement of the regulatory authorities in the US and Canada. It has no approval as a medical device in the UK as far as I can tell (and no, a CE mark is not approval for sale as a medical device). Guy (Help!) 10:30, 17 April 2014 (UTC)[reply]

Guy, you seem as an expert on medical device legislation. In the European Union any medical device that is installed and used in a medical establishment must have a CE mark. Furthermore the manufacturer must be certified for conformity to ISO9001 and ISO13845 standards. Then in each country's Health Ministry or authority a registration is required of the medical device. This procedure makes a device legal to be sold and used as a medical device. And CE mark means, besides others, that there is proof of effectiveness on specific intended use. It has been almost 10 years that I am personally involved and I know very well the law.Thecharisp (talk) 15:27, 17 April 2014 (UTC)Theharisp[reply]

I am not an expert, but a reasonably well informed lay person. I have successfully reported fraudulent medical devices to regulators in the UK. Many classes of device sold in the EU, medical or not, must carry a CE mark as a legal condition of sale in the EU; depending on risk, this may be self-certified by the manufacturer. ISO9001 is irrelevant to the claims for the device, as you well know - it's a box-ticking exercise to show you have an internal QA process, and nothing more. Medical devices (as defined by the EU Medical Devices Directive 93/42/EEC) are regulated in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) and classified according to risk, Class I, IIa, IIb or III. Low risk devices do not require proof of efficacy, clinical trials or anything else, but marketing authorisation depends on evidence presented. You may not market an NMR scanner as a cure for cancer, for example. The PAP-IMI has, as far as I can find, no approved clinical uses in the UK, which is not unexpected given that it was banned in the US and Canada. Guy (Help!) 21:31, 17 April 2014 (UTC)[reply]

First of all, now it is approved by Health Canada, and the Licence number is 81519. It was banned in the past in Canada, because it was banned in the US. In the UK it has not really been marketed but not because it is not legal. ISO9001, yes it is nothing important but ISO13485 is absolutely necessary. Both standards are a requirement by the directive 93/42 for the manufacturing of medical devices. And a medical CE mark and certificate of conformity to the 93/42 is given by a third party, an independent notified body, only if, besides others, medical efficacy is proved for the intended use of a device. One may prove medical efficacy of a device not only by clinical studies performed with the device in question, but claiming results and efficacy proven by other similar devices. Papimi device is a class IIa device, producing Pulsed ElectroMagnetic Field(aka PEMF) and belongs to the general category of magnetotherapy devices widely used in physical therapy for many years mostly for pain management and inflammation. Therefore the few clinical studies even with not too many patients performed with the Papimi device, is good enough for the relevant authorities in Europe. By what you are saying and what is written in the relevant article in Wikipedia, Health authorities in several EU and outside EU that have approved it and the notified body that has certified it are fooled! That is quite impossible. Afterall, why is it still out there and hundreds of medical professionals and often University Professors are using it and making research as well? Everyone then is a fraud, hoodwinker and part of a scam? Over the past years several companies have been manufacturing similar devices (many of them are former partners) and some of them also inside the US. Anyway, just take a look at Transcranial Magnentic Stimulation (aka rTMS) which is functioning under the same principle.Thecharisp (talk) 05:53, 18 April 2014 (UTC)[reply]

Discussion regarding your edits

There is currently a discussion at Wikipedia:Administrators' noticeboard/Incidents regarding an issue with which you may have been involved. Thank you. Guy (Help!) 12:52, 16 April 2014 (UTC)[reply]

Blocked

You have been blocked indefinitely from editing for making legal threats or taking legal action. If you think there are good reasons why you should be unblocked, you may appeal this block by adding the following text below this notice: {{unblock|reason=Your reason here ~~~~}}. However, you should read the guide to appealing blocks first.

You are not allowed to edit Wikipedia while the threats stand or the legal action is unresolved. Tiderolls 16:21, 16 April 2014 (UTC)[reply]

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Please read Wikipedia:No legal threats. Your block may be undone if you unambiguously retract your threat of legal action. I will watchlist this page in the event you have questions or require clarification. Tiderolls 16:21, 16 April 2014 (UTC)[reply]

@@ Line 15: / Line 15: @@
 :::: I am not an expert, but a reasonably well informed lay person. I have successfully reported fraudulent medical devices to regulators in the UK. Many classes of device sold in the EU, medical or not, must carry a [[CE mark]] as a legal condition of sale in the EU; depending on risk, this may be self-certified by the manufacturer. ISO9001 is irrelevant to the claims for the device, as you well know - it's a box-ticking exercise to show you have an internal QA process, and nothing more. Medical devices (as defined by the EU Medical Devices Directive 93/42/EEC) are regulated in the UK by the [[Medicines and Healthcare Products Regulatory Agency]] (MHRA) and classified according to risk, Class I, IIa, IIb or III. Low risk devices '''do not''' require proof of efficacy, clinical trials or anything else, but marketing authorisation depends on evidence presented. You may not market an NMR scanner as a cure for cancer, for example. The PAP-IMI has, as far as I can find, no approved clinical uses in the UK, which is not unexpected given that it was banned in the US and Canada. <b>[[User Talk:JzG|Guy]]</b> <small>([[User:JzG/help|Help!]])</small> 21:31, 17 April 2014 (UTC)
+::::: First of all, now it is approved by Health Canada, and the Licence number is 81519. It was banned in the past in Canada, because it was banned in the US. In the UK it has not really been marketed but not because it is not legal. ISO9001, yes it is nothing important but ISO13485 is absolutely necessary. Both standards are a requirement by the directive 93/42 for the manufacturing of medical devices. And a medical CE mark and certificate of conformity to the 93/42 is given by a third party, an independent notified body, only if, besides others, medical efficacy is proved for the intended use of a device. One may prove medical efficacy of a device not only by clinical studies performed with the device in question, but claiming results and efficacy proven by other similar devices. Papimi device is a class IIa device, producing Pulsed ElectroMagnetic Field(aka PEMF) and belongs to the general category of magnetotherapy devices widely used in physical therapy for many years mostly for pain management and inflammation. Therefore the few clinical studies even with not too many patients performed with the Papimi device, is good enough for the relevant authorities in Europe. By what you are saying and what is written in the relevant article in Wikipedia, Health authorities in several EU and outside EU that have approved it and the notified body that has certified it are fooled! That is quite impossible. Afterall, why is it still out there and hundreds of medical professionals and often University Professors are using it and making research as well? Everyone then is a fraud, hoodwinker and part of a scam? Over the past years several companies have been manufacturing similar devices (many of them are former partners) and some of them also inside the US. Anyway, just take a look at Transcranial Magnentic Stimulation (aka rTMS) which is functioning under the same principle.[[User:Thecharisp|Thecharisp]] ([[User talk:Thecharisp#top|talk]]) 05:53, 18 April 2014 (UTC)
 == Discussion regarding your edits ==